Table 3:
Percentage of patient allocation for the proposed PRO-ISO, PRO-CRM, and a nonparametric optimal benchmark over 7 dose-toxicity scenarios from Lee et al. (2020). The target C-DLT rate is 0.25, the target P-DLT rate is 0.35, and the sample sizes are and participants.
Scenario 1 | ||||||||||
Probability of C-DLT | 0.05 | 0.05 | 0.25 | 0.40 | 0.50 | 0.05 | 0.05 | 0.25 | 0.40 | 0.50 |
Probability of P-DLT | 0.17 | 0.18 | 0.35 | 0.50 | 0.65 | 0.17 | 0.18 | 0.35 | 0.50 | 0.65 |
PRO-CRM | 20.0 | 32.0 | 38.0 | 9.0 | 1.0 | 11.0 | 26.0 | 53.0 | 9.0 | 1.0 |
PRO-ISO | 14.4 | 31.7 | 39.4 | 12.2 | 2.2 | 7.8 | 30.3 | 52.3 | 8.8 | 1.0 |
TITE-PRO-ISO | 25.7 | 30.2 | 31.3 | 10.6 | 2.2 | 12.5 | 27.0 | 47.3 | 11.0 | 2.0 |
Scenario 2 | ||||||||||
Probability of C-DLT | 0.05 | 0.25 | 0.40 | 0.55 | 0.70 | 0.05 | 0.25 | 0.40 | 0.55 | 0.70 |
Probability of P-DLT | 0.10 | 0.15 | 0.35 | 0.50 | 0.65 | 0.10 | 0.15 | 0.35 | 0.50 | 0.65 |
PRO-CRM | 25.0 | 45.0 | 23.0 | 6.0 | 1.0 | 17.0 | 55.0 | 24.0 | 3.0 | 1.0 |
PRO-ISO | 20.6 | 49.4 | 24.4 | 5.0 | 0.6 | 13.8 | 60.8 | 23.0 | 2.3 | 0.3 |
TITE-PRO-ISO | 26.8 | 43.0 | 23.5 | 6.1 | 1.1 | 15.8 | 54.3 | 25.0 | 4.3 | 0.8 |
Scenario 3 | ||||||||||
Probability of C-DLT | 0.01 | 0.02 | 0.05 | 0.10 | 0.25 | 0.01 | 0.02 | 0.05 | 0.10 | 0.25 |
Probability of P-DLT | 0.04 | 0.09 | 0.17 | 0.20 | 0.35 | 0.04 | 0.09 | 0.17 | 0.20 | 0.35 |
PRO-CRM | 8.0 | 11.0 | 19.0 | 29.0 | 33.0 | 4.0 | 5.0 | 10.0 | 30.0 | 51.0 |
PRO-ISO | 7.2 | 11.1 | 18.9 | 31.7 | 30.6 | 3.0 | 4.8 | 10.0 | 39.3 | 43.0 |
TITE-PRO-ISO | 17.9 | 20.1 | 23.5 | 21.8 | 17.3 | 8.0 | 9.3 | 13.3 | 29.0 | 40.3 |
Scenario 4 | ||||||||||
Probability of C-DLT | 0.02 | 0.05 | 0.10 | 0.25 | 0.40 | 0.02 | 0.05 | 0.10 | 0.25 | 0.40 |
Probability of P-DLT | 0.09 | 0.17 | 0.20 | 0.35 | 0.50 | 0.09 | 0.17 | 0.20 | 0.35 | 0.50 |
PRO-CRM | 13.0 | 19.0 | 31.0 | 29.0 | 8.0 | 6.0 | 9.0 | 30.0 | 47.0 | 8.0 |
PRO-ISO | 10.6 | 16.7 | 31.1 | 32.8 | 8.9 | 5.3 | 8.8 | 34.3 | 43.8 | 8.0 |
TITE-PRO-ISO | 20.7 | 25.1 | 26.8 | 20.1 | 7.8 | 9.3 | 13.3 | 29.0 | 38.3 | 10.3 |
Scenario 5 | ||||||||||
Probability of C-DLT | 0.05 | 0.10 | 0.16 | 0.25 | 0.40 | 0.05 | 0.10 | 0.16 | 0.25 | 0.40 |
Probability of P-DLT | 0.05 | 0.20 | 0.35 | 0.50 | 0.65 | 0.05 | 0.20 | 0.35 | 0.50 | 0.65 |
PRO-CRM | 16.0 | 34.0 | 36.0 | 12.0 | 2.0 | 8.0 | 25.0 | 52.0 | 14.0 | 1.0 |
PRO-ISO | 12.2 | 30.6 | 36.7 | 17.2 | 3.3 | 5.3 | 29.0 | 48.5 | 16.0 | 1.5 |
TITE-PRO-ISO | 21.2 | 33.0 | 29.6 | 12.8 | 3.4 | 9.8 | 26.0 | 43.0 | 17.8 | 3.5 |
Scenario 6 | ||||||||||
Probability of C-DLT | 0.05 | 0.18 | 0.20 | 0.25 | 0.40 | 0.05 | 0.18 | 0.20 | 0.25 | 0.40 |
Probability of P-DLT | 0.17 | 0.35 | 0.50 | 0.65 | 0.80 | 0.17 | 0.35 | 0.50 | 0.65 | 0.80 |
PRO-CRM | 36.0 | 45.0 | 16.0 | 3.0 | 0.0 | 24.0 | 57.0 | 17.0 | 2.0 | 0.0 |
PRO-ISO | 30.6 | 42.8 | 20.0 | 5.6 | 1.1 | 23.0 | 55.5 | 19.0 | 2.5 | 0.3 |
TITE-PRO-ISO | 33.0 | 42.5 | 18.4 | 5.6 | 1.1 | 21.8 | 52.0 | 20.8 | 4.5 | 0.8 |
Scenario 7 | ||||||||||
Probability of C-DLT | 0.01 | 0.05 | 0.10 | 0.16 | 0.25 | 0.01 | 0.05 | 0.10 | 0.16 | 0.25 |
Probability of P-DLT | 0.04 | 0.05 | 0.20 | 0.35 | 0.50 | 0.04 | 0.05 | 0.20 | 0.35 | 0.50 |
PRO-CRM | 8.0 | 14.0 | 32.0 | 34.0 | 12.0 | 4.0 | 6.0 | 24.0 | 51.0 | 15.0 |
PRO-ISO | 7.2 | 13.3 | 29.4 | 35.6 | 14.4 | 3.0 | 5.5 | 28.5 | 48.3 | 14.8 |
TITE-PRO-ISO | 17.9 | 20.7 | 28.5 | 22.3 | 11.2 | 8.0 | 9.8 | 24.8 | 40.0 | 17.5 |